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SMC gives green light for BMS’ Opdivo

Scotland will be first UK country to access the drug after NICE refusal

Bristol-Myers SquibbLung cancer patients in Scotland will be the first in the UK to access Bristol-Myers Squibb's immunotherapy Opdivo via the NHS, following a recommendation by the Scottish Medicines Consortium (SMC).

It is a boost for the manufacturer after NICE last week refused to recommend Opdivo (nivolumab) in England as a treatment for kidney cancer.

The PD-1 immune checkpoint inhibitor extends overall survival in post-chemotherapy patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) - a particularly aggressive sub-type of lung cancer with limited treatment options.

NSCLC patients tend to be diagnosed in the later stages of the disease, which typically has a poor prognosis with an overall survival time of six months.

The additional three to four months' survival time and improved quality of life that Opdivo can offer is therefore a significant gain.

Meanwhile, the SMC also approved Pfizer's lung cancer therapy Xalkori (crizotinib) for patients with ALK-positive NSCLC.

Average survival for this rare sub-type is less than one year, and generally affects a younger age group than other lung cancers. Pfizer's oral treatment can delay disease progression for an average of four months.

The ALK inhibitor has been approved as second-line therapy for ALK-positive NSCLC patients since 2012 and is now available in more than 85 countries worldwide.

It was approved for a label update by the European Commission in December last year, authorising the drug for use as a first-line treatment of ALK-positive patients.

Lung cancer is a considerable health burden for Scotland with incidence rates that are among the highest in the world – it accounted for 25% of the country's cancer deaths in 2014.

Additionally, the SMC gave three further approvals to Lundbeck's antidepressant Brintellix (vortioxetine), Novartis' Cosentyx (secukinumab) for ankylosing spondylitis, and UCB's Briviact (brivaracetam) for partial-onset seizures in epilepsy sufferers.

Article by
Adam Hill

11th July 2016

From: Regulatory

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